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| Name | Class |
|---|---|
| Comenius University | OTHER |
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This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of high-dose short-chain fatty acid (SCFA) supplementation on the gut microbiome and host metabolome in stable kidney transplant recipients. Participants will be randomly assigned to receive either 1000 mg of sodium butyrate per day or placebo for a duration of 12 weeks. Comprehensive profiling of the serum and urinary metabolome, along with analysis of the gut microbiome composition and diversity, will be conducted at three time points: baseline, after the intervention period (week 12). The biochemical parameters and the level of tacrolimus will be also examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCFA group | Experimental | Participants randomized at study with ID: TNO_UNM_SCFA1 to this group will receive 1000 mg of sodium butyrate daily for 12 weeks. The intervention aims to evaluate the effect of high-dose SCFA supplementation on the gut microbiome and systemic/urinary metabolome in kidney transplant recipients. The effect of different dosage of SCFA between study TNO_UNM_SCFA1 and TNO_UNM_SCFA2 will be examined also. |
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| Placebo group | Placebo Comparator | Participants in this group will receive placebo capsules identical in appearance to the active SCFA capsules, administered twice daily for 12 weeks. This arm serves as a control to evaluate the specific effects of SCFA supplementation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCFA | Dietary Supplement | Participants randomized to this group will receive 1000 mg of sodium butyrate daily for 12 weeks. The intervention aims to evaluate the effect of high-dose SCFA supplementation on the gut microbiome and systemic/urinary metabolome in kidney transplant recipients. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gut microbiome composition after SCFA supplementation | Evaluation of gut microbiota diversity and composition (alpha and beta diversity indices, relative abundance of microbial taxa) via 16S rRNA gene sequencing from stool samples. | Baseline to Week 12 |
| Change in serum and urine metabolomic profile after higehr dose of SCFA supplementation | Analysis of systemic metabolic changes using untargeted metabolomic profiling (NMR) in serum and urine samples and comarisation with results in study TNO_UNM_SCFA1. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of high-dose SCFA supplementation | Recording of adverse events (AEs), such as gastrointestinal symptoms. | Baseline to Week 12 |
| Correlation between gut microbiome composition and serum metabolome. |
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Inclusion Criteria:
Stable kidney transplant recipients (≥ 6 months post-transplantation)
Stable graft function defined as eGFR ≥ 30 mL/min/1.73 m² with no significant change (>15%) in the last 3 months
No episodes of acute rejection within the last 6 months
On stable immunosuppressive therapy for at least 3 months
Ability to provide written informed consent
Willingness and ability to provide stool, urine, and blood samples at specified time points
Exclusion Criteria:
Active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, celiac disease)
Severe intestinal motility disorders or chronic diarrhea
Advanced liver disease (Child-Pugh C)
Active infection or systemic inflammatory disease requiring treatment
Uncontrolled diabetes mellitus (HbA1c > 9%)
Known allergy or intolerance to SCFA or ingredients in the supplement
Participation in another interventional clinical trial within the past 30 days
Pregnancy or breastfeeding
Hospitalization within 30 days prior to enrollment
Any condition which, in the opinion of the investigator, may compromise the safety of the participant or the integrity of the study data
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Martin | Martin | Slovakia | 03601 | Slovakia |
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| Placebo | Dietary Supplement | Participants in this group will receive placebo capsules (sacharosis) identical in appearance to the active SCFA capsules, administered twice daily for 12 weeks. This arm serves as a control to evaluate the specific effects of SCFA supplementation. |
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Exploratory analysis of correlantion between gut microbiome composition and serum metabolites.
| Baseline to week 12 |
| Intolerance of high dose SCFA. | Recording of treatment discontinuation rates due to intolerance or side effects. | Baseline to Week 12. |
| correlantion between gut microbiome composition and urinary metabolites | Exploratory analysis of correlantion between gut microbiome composition and urinary metabolites. | Baseline to week12 |